Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-09-10-Speech-1-229-000"

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"Madam President, I, too, would like to thank Ms McAvan and the shadow rapporteurs once again. I believe that the European Union has acted very quickly here. Something that was regarded as modern and effective as recently as 2010 has proven to be inadequate in such a short space of time, and we must now act together as quickly as possible to put it in order. These loopholes need to be closed. The document before us shows very clearly where work needs to be done. We need transparency and we need speed, as we need patients and consumers to have confidence in their drugs. Above all, we need confidence in the system. We need close collaboration in order for it still to be possible to later monitor medicinal products that have already been authorised in Europe, in order to be able to ensure that adverse reactions and, above all, harmful side effects are detected as quickly as possible and that the entire European market is informed in the shortest possible time. In other words, medicines cannot simply quietly and secretly disappear from the market when producers have noticed that there may be some harmful side effects. Instead, such occurrences must be explained. We need this transparency, we need the urgency and we also need the longer monitoring periods. What we very particularly need is the close cooperation with the patient, but also with the staff working in health care, as I believe that the pharmacovigilance package can ultimately only work if everyone knows about it, in other words, if this information also coalesces. Legislation of this kind can only really work if patients are able to make sense of the package insert and if, on the other side of the coin – as Ms McAvan mentioned – the European Medicines Agency also has the necessary financial means to be able to meet all the responsibilities handed over to it in future."@en1
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